RAVONA Containment Isolators for OEB 4-6 and HPAPI:
At RAVONA, we specialize in designing and manufacturing advanced containment isolators that provide the highest level of safety when handling the most toxic and hazardous substances. Our isolators are specifically engineered to manage materials classified in the Occupational Exposure Bands (OEB) 4-6, with a particular focus on High-Potency Active Pharmaceutical Ingredients (HPAPI). These materials, used extensively in pharmaceutical manufacturing and biotechnology, require the strictest containment protocols to ensure safety for both operators and the surrounding environment.
Understanding OEB 4-6 and HPAPI: Toxicity and Safety RequirementsToxicity and Safety Requirements
The Occupational Exposure Bands (OEB) classify materials based on their toxicity and the associated health risks. The higher the OEB number, the more hazardous the material. HPAPIs, which are often used in the development of potent drug therapies, generally fall within the OEB 4-6 categories due to their extreme toxicity. Here’s a breakdown of the OEB bands in relation to RAVONA’s containment isolators:
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OEB 4 – High Toxicity
- Description: Materials in OEB 4 are highly toxic and pose significant risks to human health, even in small quantities. These substances are often associated with HPAPIs used in oncology treatments, making strict containment a necessity.
- Containment Measures: Negative pressure isolators equipped with HEPA filtration ensure that any airborne contaminants are contained within. Glove ports allow for safe, glove-assisted handling while remote systems minimize direct exposure. These measures ensure that HPAPI substances and other OEB 4 materials remain safely handled, preventing contamination and exposure.
- Examples: Cytotoxic drugs, highly potent oncology treatments, and some biotech materials.
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OEB 5 – Very High Toxicity
- Description: OEB 5 materials are extremely hazardous and even trace exposure can result in severe health consequences. HPAPI compounds used in high-potency pharmaceuticals typically fall under this category.
- Containment Measures: To ensure safety, negative pressure systems combined with advanced filtration technologies (e.g., ULPA filters) are essential. Real-time environmental monitoring ensures that no toxic particles are released, while automated systems or glove-assisted handling further reduce the risk of direct exposure.
- Examples: Highly potent biologics, experimental pharmaceutical agents, and other high-risk HPAPIs.a
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OEB 6 – Critical Toxicity (Most Hazardous)
- Description: OEB 6 materials are the most toxic substances, where even the smallest exposure can have devastating health effects. These substances require maximum containment to prevent accidental exposure.
- Containment Measures: For OEB 6 materials, including certain HPAPI compounds, RAVONA’s isolators utilize negative pressure, HEPA and ULPA filtration to ensure no contaminants escape. Glove ports, robotic systems, and automated handling processes are used to completely eliminate any direct exposure. Continuous air quality monitoring ensures the isolator’s integrity.
- Examples: High-potency cytotoxic drugs, genetically modified organisms (GMOs), and extremely potent high-concentration APIs.
We Comply with the Following Standards and Guidelines
Benefit from optimal glove integrity, and maximum peace of mind.
RAVONA’s Containment Isolators for OEB 4-6 and HPAPI:
Key Features and Capabilities
RAVONA’s containment isolators are designed to meet the most rigorous safety standards for handling OEB 4-6 materials, particularly HPAPIs. Here’s how we ensure maximum protection for both workers and the environment:
Negative Pressure Systems: Our isolators are designed with negative pressure to ensure that hazardous materials, including HPAPI compounds, remain contained within the isolator. This prevents any harmful substances from escaping into the surrounding environment.
Advanced Filtration Technologies: Equipped with HEPA and ULPA filters, our isolators capture particles down to the nanogram level, ensuring that even the smallest quantities of HPAPI and OEB 4-6 materials are safely contained.
Real-Time Environmental Monitoring: Our isolators are equipped with real-time monitoring systems that track air quality, pressure levels, and particulate contamination. This ensures that the isolator’s conditions remain stable, and any issues are flagged immediately, minimizing risks of exposure.
Glove Ports and Remote Handling: To minimize direct exposure, glove ports allow for safe, glove-assisted handling, and automated or robotic systems allow for remote interaction with the hazardous materials. This ensures that operators are never in direct contact with HPAPI or OEB 4-6 substances.
Customizable Solutions: Each process is unique, and we provide fully customizable containment isolators designed to meet your specific requirements, whether you are handling HPAPIs, potent drugs, or other hazardous materials.
Applications of RAVONA’s OEB 4-6 and HPAPI Containment Isolators
Why Choose RAVONA for OEB 4-6 and HPAPI Containment Solutions?
At RAVONA, we understand the specific challenges of handling HPAPI and OEB 4-6 materials. Our containment isolators are designed to provide the highest level of safety and ensure compliance with global regulatory standards. We partner closely with clients to offer tailored containment solutions that fit their needs, improving both worker safety and operational efficiency.
Maximum Protection: Our isolators ensure that HPAPI and OEB 4-6 materials are safely contained, preventing exposure to hazardous substances.
Regulatory Compliance: All RAVONA isolators meet the FDA, cGMP, and OSHA standards, ensuring that your processes comply with the most rigorous safety requirements.
Tailored Solutions: RAVONA works with you to design isolators that are specifically customized to your needs, whether handling HPAPI, cytotoxic drugs, or other hazardous materials.
Contact RAVONA Today
Let RAVONA enhance the safety and efficiency of your operations with our advanced containment isolators for OEB 4-6 materials and HPAPI. Contact us today to discuss how we can assist you in safely managing potent and hazardous substances.
Application:
✓ Production of cytostatic in glass reactors, API filter, weighing, packing.
✓ Reactor charging.
✓ ATEX Isolators.
✓ Dispensing Isolators.
✓ Laboratory isolator with vacuum Oven.
✓ Isolator with vacuum oven dryer, conical mill and high shear mixer.
✓ Isolator for filter dryer.
✓ Reactor sampling.
✓ Filling, emptying of barrels.
✓ Isolator for freeze dryer.
✓ Isolator with teflon coating.
✓ Isolators with vacuum Ovens.
✓ Isolator with analytical scales.
✓ Inert enviorment Isolators.
✓ Washing isolator.
✓ Lab weighing isolator.
✓ BDTD isolator.
✓ Mixers integration.
